CapsoVision Inc(CV) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights CapsoVision achieved robust performance growth in Q2 2025, driven by increasing CapsoCam Plus adoption, a successful IPO funding future growth, and key product development milestones including FDA 510(k) submission for CapsoCam Colon and planned AI module integration Recent Highlights The company achieved significant revenue growth in Q2 2025, with a substantial increase in new customers, expanded CapsoCam Plus patient usage, key product pipeline advancements, and a successful IPO completion Second Quarter 2025 Business Highlights | Metric | Q2 2025 | Q2 2024 | Year-over-Year Growth | | :--- | :--- | :--- | :--- | | Total Revenue | $3.3 million | $2.843 million | 17% | | New Accounts | - | - | 75% | | CapsoCam Plus Patient Usage | Over 143,000 | - | - | | IPO Net Proceeds | $23.4 million | - | - | - Submitted a 510(k) notification to the FDA in June 2025 for CapsoCam Colon, a non-invasive capsule for colon imaging[10] - Completed an Initial Public Offering (IPO) on July 3, 2025, raising approximately $23.4 million in net proceeds[9][10] Management Commentary CEO Johnny Wang highlighted robust CapsoCam Plus adoption and growing physician interest in the capsule endoscopy pipeline, noting the IPO provides capital for accelerated growth and new indications, with confidence in future AI module integration and CapsoCam Colon development - CapsoCam Plus achieved stable adoption in small bowel imaging, with increasing physician interest in the capsule endoscopy product line[4] - Successfully completed an IPO, securing additional capital to accelerate growth and expand into high-impact new indications[4] - Near-term goals include submitting and obtaining FDA 510(k) clearance, integrating proprietary AI modules into CapsoCam Plus, and continuing development and regulatory approval for CapsoCam Colon[5] - Anticipates advancing pancreatic cancer and esophageal varices programs, where panoramic imaging offers distinct clinical advantages and early detection potential[5] Financial Performance Overview CapsoVision achieved year-over-year growth in revenue and gross profit in Q2 2025, effectively managing operating expenses through the completion of key research and clinical trials, with a significant capital injection from the July IPO despite reduced cash and cash equivalents Second Quarter 2025 Financial Results Summary In Q2 2025, total revenue grew by 17% year-over-year, driven by increased CapsoCam Plus capsule sales, with stable gross profit and margin, reduced operating expenses due to completed trials, and cash and cash equivalents of $1.1 million as of June 30, supplemented by $23.4 million net IPO proceeds in July Second Quarter 2025 Financial Highlights | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $3.3 million | $2.843 million | 17% increase | | Gross Profit | $1.8 million | $1.592 million | $0.2 million (14%) increase | | Gross Margin | 55% | 56% | 1 percentage point decrease | | Operating Expenses | $6.5 million | $6.863 million | $0.4 million decrease | | Cash and Cash Equivalents (as of June 30) | $1.1 million | - | - | - The decrease in operating expenses is primarily attributed to lower costs associated with the completion of key research and clinical trials[8] Company Information CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-driven solutions to revolutionize GI disease detection and diagnosis, with its core product CapsoCam Plus commercially available and an active innovative product pipeline including CapsoCam Colon About CapsoVision CapsoVision is a commercial-stage medical technology company dedicated to transforming GI disease detection and diagnosis through advanced imaging and AI, featuring its flagship CapsoCam Plus® wireless panoramic capsule endoscope for high-resolution small bowel visualization, and developing CapsoCam Colon with enhanced AI for non-invasive colon imaging and polyp detection, with plans to expand its platform to various GI indications including esophageal and pancreatic diseases - CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-driven solutions to transform the detection and diagnosis of gastrointestinal diseases[13] - Its flagship product, CapsoCam Plus®, is a wireless, panoramic capsule endoscope enabling high-resolution visualization of the small bowel, supporting cloud-based or direct capsule video retrieval[13] - The next-generation product, CapsoCam Colon, integrates enhanced AI, aiming for non-invasive colon imaging and polyp detection[13] - The company's proprietary platform is designed to expand into multiple gastrointestinal indications, including esophageal and pancreatic diseases[13] Condensed Financial Statements (Unaudited) This section presents CapsoVision's unaudited condensed financial statements, including statements of operations for the three and six months ended June 30, 2025 and 2024, balance sheets as of June 30, 2025 and December 31, 2024, and statements of cash flows for the six months ended June 30, 2025 and 2024 Condensed Statements of Operations and Comprehensive Loss This table presents the company's unaudited operating and comprehensive loss for Q2 and the first half of 2025 and 2024, detailing revenue, costs, operating expenses, operating loss, and ultimately net loss and net loss per share Condensed Statements of Operations and Comprehensive Loss | Metric (K USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Revenue | 3,315 | 2,843 | 6,098 | 5,338 | | Cost of Sales | 1,504 | 1,251 | 2,793 | 2,352 | | Gross Profit | 1,811 | 1,592 | 3,305 | 2,986 | | Total Operating Expenses | 6,462 | 6,863 | 13,338 | 12,466 | | Operating Loss | (4,651) | (5,271) | (10,033) | (9,480) | | Net Loss and Comprehensive Loss | (4,625) | (5,266) | (10,000) | (9,465) | | Net Loss Per Share – Basic and Diluted (USD) | (2.02) | (2.58) | (4.49) | (4.84) | Condensed Balance Sheets This table provides unaudited balance sheets as of June 30, 2025, and December 31, 2024, detailing the company's assets, liabilities, convertible preferred stock, and stockholders' deficit Condensed Balance Sheets | Metric (K USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | 1,066 | 9,319 | | Total Current Assets | 7,799 | 14,847 | | Total Assets | 9,547 | 16,803 | | Total Current Liabilities | 4,221 | 1,801 | | Total Liabilities | 4,908 | 2,688 | | Total Convertible Preferred Stock | 143,625 | 143,625 | | Total Stockholders' Deficit | (138,986) | (129,510) | Condensed Statements of Cash Flows This table presents the company's unaudited cash flows for the first half of 2025 and 2024, detailing cash flows from operating, investing, and financing activities, along with the ending cash balance Condensed Statements of Cash Flows | Metric (K USD) | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (9,512) | (7,636) | | Net Cash Used in Investing Activities | (70) | (149) | | Net Cash Provided by Financing Activities | 1,202 | 72 | | Net Decrease in Cash | (8,380) | (7,713) | | Cash at End of Period | 1,066 | 6,819 | Supplementary Information This section provides details on the company's Q2 2025 financial results conference call and webcast, important forward-looking statements, and investor and media contact information Conference Call and Webcast Details CapsoVision will host a conference call on August 14, 2025, to discuss its second-quarter financial results, with investor participation available via phone or the company's investor relations website - The conference call to discuss Q2 financial results will be held on August 14, 2025, at 4:30 PM ET[11] - Domestic dial-in is (800) 715-9871, international dial-in is (646) 307-1963, and the conference ID is 1668374[11] - A webcast link is available in the investor relations section of www.capsovision.com, with a replay accessible on the website for one year[11][12] Forward-Looking Statements This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, concerning future events and financial performance, based on current expectations and involving significant risks and uncertainties where actual results may differ materially - Forward-looking statements involve future events, business, and financial performance, including words such as "anticipate," "expect," and "intend"[14] - These statements are based on current expectations and involve significant risks and uncertainties, including market conditions, financial position, failure to obtain regulatory approvals, and product adaptability failures[14] - Actual results and timing of events may differ materially from forward-looking statements, and the company undertakes no obligation to update or revise these statements unless required by law[14] Investor and Media Contacts Provides detailed contact information for CapsoVision's investor relations and media contacts - Investor Relations Contact: Leigh Salvo, New Street Investor Relations, Email: Investors@CapsoVision.com[15] - Media Contacts: Leslie Strickler and Paul Spicer, Être Communications, Email: leslies@etrecommunications.com | pauls@etrecommunications.com[15]